PIC/S PI 006-4 and its 2 linked instruments

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	PIC/S PI 006-4	PIC/S GMP Guide PE 009	Annex 15
Authority	PIC/S	PIC/S	European Commission
Legal weight	Guidance & Q&A	GMP guide & annexes	GMP guide & annexes
Status	Final	In force	In force
Last verified	Not yet	Not yet	Not yet
Summary	PIC/S recommendations on qualification and validation, updating PI 006-3 of 2007. Link only.	The PIC/S GMP guide used by participating inspectorates, including an annex on computerised systems equivalent to EU Annex 11. PIC/S co-drafts the current EU revisions.	The EU GMP annex on qualification and validation.
Lifecycle	1 Oct 2026 Version PI 006-4 dated 1 Oct 2026	23 Sep 2026 PE 009-18 published (revised Annex 19, reference and retention samples); supersedes PE 009-17	1 Oct 2015 Came into operation
Source	Official text Summary in our own words. See the official text from PIC/S.	Official text Summary in our own words. See the official text from PIC/S.	Official text Source: European Commission. Licensed under CC BY 4.0.

These facts are placed side by side from each record. This page does not say which is stricter or whether requirements differ. Read the official texts.